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2013session2 3
1. COMPLEX SFA INTERVENTIONS:
Gilles Soulez, MD, MSc
Professor of Radiology
Academic Chair dpt of Radiology, Nuclear Medicine
and Radiation Oncology
CHUM-University of Montreal
2. Introduction
• Lot of technological evolution in the
endovascular management of SFA disease
– 3rd and 4th generation of nitinol stents
– Covered and DE stents
– DEB
– Atherectomy
– Re-entry devices
– Bioabsorbable vascular scaffold
• Need first to focus on the clinical indication
4. SFA Patency vs. Mean Lesion Length
• Historically, there’s been a direct relationship between lesion length
and patency rate in SFA trials
FAST
(Luminexx)
FACT
(Conformexx)
RESILIENT
(LifeStent)
Astron
(Biotronik)
DURABILITY
(Everflex)
Vienna
(Absolute)
Super SL
(SMART)
VIBRANT
(BMS arm)
0
10
20
30
40
50
60
70
80
90
100
0.00 5.00 10.00 15.00 20.00 25.00 30.00
PatencyRate(12mo)
Mean Lesion Length (cm)
DURABILITY 200
(Everflex)
Leipzig SFA Registry
(SUPERA)
CWZ
(SUPERA)
5. Long-term clinical impact ?
• RESILIENT 36 MONTHS
– Survival
• 90% vs. 91.7%, p = 0.71
– Major adverse events
• 75.2% vs. 75.2%, p = 0.98
– target lesion revascularization
• stent group (75.5%)
• angioplasty group (41.8%), p<0.0001.
– No difference in QOL at 2 and 3 years based upon the SF-8
questionnaire and WIQ.
– Significant improvement in quality of life for both treatment
groups compared to baseline at all study time intervals.
Laird et al JEVT 2012
7. When shoud we perform primary
stenting?
• Our practice
– More than 90% stenting overall !
– Primary stenting
• Lesion length more than 4cm
• CTO
• Recurrence post angioplasty
– Provisional
• Single stenosis less than 4 cm
8. Stent Fractures – what we know today
• Major stent fractures (types 3 and 4) are
clearly linked to reocclusion
• Different nitinol stent designs have
different fracture rates and types
• Fractures ↑ with Length of lesion and
number of overlapping stents
• Elongation of the stent during deployment
predisposes to severe stent fracture
9. SUPERA Stent (IDEV)
• Nitinol woven design
• High radial strength (4X) (especially if Ca++)
• High flexibility (kink resistant)
• High resistance to fractures
15. Covered stent
• Patency not different from
above the knee synthetic
bypass
• Potential indications
– No venous conduit
– Long lesion > 20cm
– Large arteries 6mm and more
– Not too calcified
– In stent stenosis ?
Mc Quade K et al. J Vasc Surg 2010;53:584-90
34. Limitations
• Short stent 8cm
• Need to overlap several stents for long lesions
• Cost
• Positive clinical impact required to justify the
cost
• DEB for ISR good alternative ?
35. Indication of DES ?
• ISR (drug coated balloon is an alternative)
• Patient at high risk for restenosis by IH
– Small arteries
– Poor run-off
– History of IH
– Recurrence post-angioplasty
– Long lesions
• Calcified lesions ?
36. Drug eluting balloon
• Potential advantage
– Stent can be optional
– Significant drug transfer to the wall and drug
effect
– ISR
• Potential limitation
– No stent or vascular scaffold
37. DEB
• Paclitaxel combined with a
carrier
– Iopromide, Ultravist, BTHC, urea
• Drug remains in arterial wall for
weeks
• Effectively inhibits neointimal
proliferation
38. Supportive data
6m Late
Lumen Loss
6m angiographic
restenosis
6m TLR 18-24m
TLR
Trial Size LL [mm] n (%) TLR TLR
FemPac DEB
n=45
0.5 1.1 6/31 (19) 9% 20%
PTA
n=42
1.0 1.1 16/34 (47) 33% 48%
Thunder DEB
n=48
0.4 1.2 7/41 (17) 4% 15%
PTA
n=54
1.7 1.8 21/48 (44) 37% 52%
51. DEB & ISR SFA
• Single arm study
(12 months FU)
– 39 patients with
ISR
• Primary patency
92%
• All patients
asymptomatic
Stabile E et al. JACC 2012
